Device, system, and method for transcatheter treatment of valvular regurgitation

Abstract

The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance element for implantation across the valve; a system including the coaptation assistance element and anchors for implantation; a system including the coaptation assistance element and delivery catheter; and a method for transcatheter implantation of a coaptation element across a heart valve.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]The present application is a continuation-in-part application of U.S. application Ser. No. 16 / 129,194 filed Sep. 12, 2018, which is a continuation-in-part application of U.S. application Ser. No. 15 / 918,988 filed Mar. 12, 2018, which claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 62 / 470,684, filed on Mar. 13, 2017. Each of the foregoing applications of which are hereby incorporated by reference in their entireties. Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application, are hereby incorporated by reference in their entirety under 37 CFR 1.57.BACKGROUNDField[0002]The present disclosure generally provides improved medical devices, systems, and methods, typically for treatment of heart valve disease and / or for altering characteristics of one or more valves of the body. Embodiments include implants for treatment of ...

AI Technical Summary

Benefits of technology

The patent describes a device called the coaptation assistance element, which can be used during a surgical procedure to repair damaged tissue. The device has several advantages, including that it can be easily retrieving, repositioned, and removed from the patient. It is designed to be expanded and secured in place using a primary anchor and one or more secondary anchors. The device can be delivered through a catheter and has a low profile configuration for easy placement. The method for using the device includes engaging the primary anchor with the annulus tissue and using a secondary anchor to provide additional support. The device can be partially or fully retracted during the procedure to prevent entanglement and maintain its position. Overall, the coaptation assistance element provides a tool for surgeons to repair damaged tissue with greater precision and ease.

Problems solved by technology

A variety of therapies have been applied for treatment of mitral valve regurgitation, and still other therapies may have been proposed but not yet actually used to treat patients.

However, medications can suffer from lack of patient compliance.

A significant number of patients may occasionally (or even regularly) fail to take medications, despite the potential seriousness of chronic and / or progressively deteriorating mitral valve regurgitation.

Pharmacological therapies of mitral valve regurgitation may also be inconvenient, are often ineffective (especially as the condition worsens), and can be associated with significant side effects (such as low blood pressure).

Regardless, open mitral valve surgery is generally a very invasive treatment carried out with the patient under general anesthesia while on a heart-lung machine and with the chest cut open.

Complications can be common, and in light of the morbidity (and potentially mortality) of open-heart surgery, the timing becomes a challenge—sicker patients may be in greater need of the surgery, but less able to withstand the surgery.

Procedures that are done with robots or through endoscopes are often still quite invasive, and can also be time consuming, expensive, and in at least some cases, quite dependent on the operator's skill.

While these various approaches and tools have met with differing levels of acceptance, none has yet gained widespread recognition as an ideal therapy for most or all patients suffering from mitral valve regurgitation.

Unfortunately, sealing between the native leaflets and the full perimeter of a balloon or other coaxial body may prove challenging, while the significant contraction around the native valve annulus during each heart beat may result in significant fatigue failure issues during long-term implantation if a buttress or anchor interconnecting cross member is allowed to flex.

Moreover, the significant movement of the tissues of the valve may make accurate positioning of the implant challenging regardless of whether the implant is rigid or flexible.

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